While the technology used in the Boots 56-90-447, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|BIHS (UK and IRL)||Self-measurement||Manufacturer declaration of equivalence|
|ESH (Europe)||Self-measurement||The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.|
Ware A, Stevens R, Selwood M, Fleming S. Accuracy of blood pressure monitors available in high street pharmacies. Blood Press Monit. 2016 Feb;21(1):59-61. doi: 10.1097/MBP.0000000000000151. PMID: 26427055.
Measurements from the Boots 5690447 are compared to those from the Omron BPM tester PA-350, though not in a formal validation.
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Omron MX3 Plus (HEM-742-E)
Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron MX3 Plus oscillometric blood pressure monitoring device according to the European Society of Hypertension international protocol. Blood Press Monit. 2005 Jun;10(3):165-8. PMID: 15923819.
ESH-IP:2002 - Pass General population
Christofaro DG, Casonatto J, Polito MD, Cardoso JR, Fernandes R, Guariglia DA, Gerage AM, de Oliveira AR. Evaluation of the Omron MX3 Plus monitor for blood pressure measurement in adolescents. Eur J Pediatr. 2009 Nov;168(11):1349-54. Epub: 2009 Feb 17. doi: 10.1007/s00431-009-0936-x. PMID: 19221789.
BHS:1993 - Pass (A/A) General population
SP10:1996 - Pass General population